Efficacy of the Application of Xylocaine Impregnated Compress in Reducing Per-procedural Pain During Ultrasound-guided Infiltration of Trigger Finger

Assistance Publique - Hôpitaux de Paris60 enrolled

Overview

The purpose of this study is to assess the efficacy of Xylocaine impregnated compress in reducing per-procedural pain during ultrasound-guided infiltration of Trigger Finger

Trigger finger ultrasound-guided infiltrations are frequent and painful invasive procedures. However, there is no current recommendation for per-procedural pain management, and in the majority of cases, infiltration is performed without prior skin anesthesia. Xylocaine patches are of controversial efficacy in pain acute management. In current practice, they are not prescribed in advance and they are not well adapted to the topography of the finger. On the other hand, a recent study showed the interest of administering lidocaine 2% by J-tip, a needle-free injection technique not available in France, before infiltration of Trigger Finger. The investigators hypothesize that an impregnated compress in Xylocaine 20 mg/ml injectable solution, applied 15 minutes before the procedure, would reduce per-procedural pain.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Trigger Finger

Interventions

Lidocaïne Aguettant 20 mg/mlDRUG

Lidocaïne Aguettant 20 mg/ml, injectable solution, applied to the skin with an impregnated compress, applied 15 minutes before infiltration performed by an experienced operator.

NaCl 0,9%DRUG

Placebo (NaCl 0,9%), applied to the skin with an impregnated compress, applied 15 minutes before infiltration performed by an experienced operator.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged 18 years or older * Trigger Finger (clinically defined by painful difficulty or protrusion when extending the finger) with an ultrasound-guided infiltration of cortisone derivatives indication. * Written consent * Affiliation to a Social Security system * Prior medical examination Exclusion Criteria: * Neurological conditions affecting the hand other than carpal tunnel syndrome * Intra-articular infiltration of the hand or the wrist ≤ 2 months * Allergy to Xylocaine * Contraindication to Xylocaine or cortisone derivatives * Cognitive or behavioral disorders that make assessment impossible * Persons referred to in articles L 1121-5; 6; 8; 9 of the Public Health Code (protected adults, under guardianship or curatorship, etc) * Pregnancy and breastfeeding; absence of contraceptive method for women of childbearing age * Participant unable to speak, read and write French

Locations (1)

Cochin hospital

Paris, France

RECRUITING

Outcomes

Primary Outcomes

Average pain intensity during the ultrasound-guided infiltration.

Evaluation assessed by self-administered pain numeric rating scale (0, no pain and 100, maximum pain).

Time frame: Day 0, immadiately after infiltration

Secondary Outcomes

Adverse Events

Adverse events based on a self-administered open-ended question

Time frame: Day 0

Pain acceptance level in patients with trigger finger during the ultrasound-guided infiltration

Pain acceptance will be assessed according to the patient himself on a self-administered scale (0, not at all acceptable and 100, completely acceptable).

Time frame: Day 0

Pain acceptance level assessed by the operator during the ultrasound-guided infiltration of trigger finger

Pain acceptance will be assessed according to the operator, on a scale (0, not at all acceptable and 100, completely acceptable).

Time frame: Day 0

Central Contacts

Henri GUERINI, MD

CONTACT

+33 1 58 41 25 02 henri.guerini@aphp.fr

Laetitia PEAUDECERF, PhD

CONTACT

+33 1 58 41 12 13 laetitia.peaudecerf@aphp.fr

Data from ClinicalTrials.gov

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